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Mentor Medical Ltd

⚠️ Moderate Risk

FEI: 3003916770 • West Sussex / • UNITED KINGDOM

FEI

FEI Number

3003916770

📍

Location

West Sussex /

🇬🇧
🏢

Address

Ut 10 Commerece Wa, , West Sussex /, , United Kingdom

Moderate Risk

FDA Import Risk Assessment

31.7
LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

2
Total Refusals
2
Unique Violations
12/13/2007
Latest Refusal
2/16/2006
Earliest Refusal

Score Breakdown

Violation Severity
63.3×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
11.0×10%
How is this score calculated?

Proprietary Algorithm

  • 40% Violation Severity — AI-assessed (1-10)
  • 30% Refusal Volume — Logarithmic scale
  • 20% Recency — Decays over 5 years
  • 10% Frequency — Refusals per year

© ImportRefusal.com Original Analysis

Violation Summary

5082×

NO 510(K)

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.

1181×

NOT LISTED

It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

Refusal History

DateProductViolationsDivision
12/13/2007
76MMTRESIN, ROOT CANAL FILLING CONTAINING CHLOROFORM
118NOT LISTED
508NO 510(K)
New Orleans District Office (NOL-DO)
2/16/2006
79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE
508NO 510(K)
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Mentor Medical Ltd's FDA import refusal history?

Mentor Medical Ltd (FEI: 3003916770) has 2 FDA import refusal record(s) in our database, spanning from 2/16/2006 to 12/13/2007.

What is an FEI number?

FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. Mentor Medical Ltd's FEI number is 3003916770.

What types of violations has Mentor Medical Ltd received?

Mentor Medical Ltd has been cited for 2 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.

Where does this information about Mentor Medical Ltd come from?

All FDA import refusal data for Mentor Medical Ltd is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.

Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.